BRISBANE, Calif. – Vera Therapeutics, Inc. (NASDAQ:VERA), a biotech firm specializing in immunological disease treatments, announced today that the FDA has granted Breakthrough Therapy Designation to its drug atacicept for treating IgA nephropathy (IgAN). This designation is based on Phase 2b ORIGIN trial data, indicating that atacicept could significantly improve upon existing therapies for IgAN, a serious autoimmune kidney disease.
The FDA’s decision hinges on the trial’s findings that atacicept may enhance kidney function, as evidenced by eGFR measurements, more effectively than current treatments. Dr. Marshall Fordyce, CEO of Vera Therapeutics, expressed optimism about atacicept’s potential as a transformative therapy for IgAN patients.
The Phase 2b ORIGIN trial assessed atacicept’s efficacy in maintaining eGFR over a 72-week treatment period. Patients initially underwent a 36-week double-blind phase, followed by a 36-week open-label extension with self-administered atacicept. Results showed eGFR stabilization, aligning with general population profiles rather than those with IgAN.
The trial, which included 116 patients at high risk of IgAN progression despite existing medication, met primary and secondary endpoints, demonstrating significant proteinuria reduction and eGFR stabilization through week 36. Atacicept’s safety profile was similar to placebo.
Vera Therapeutics plans to release 96-week results from the Phase 2b trial later this year and anticipates primary endpoint results from the Phase 3 ORIGIN 3 trial in the first half of 2025 to support regulatory approval submissions for atacicept in IgAN.
The FDA’s Breakthrough Therapy Designation aims to expedite the development and review of drugs for serious conditions where preliminary evidence suggests a substantial improvement over existing therapies. Atacicept’s designation reflects its potential to meet this criterion for IgAN treatment.
The Phase 3 ORIGIN 3 trial is currently evaluating atacicept’s safety and efficacy in a larger patient cohort, with a primary focus on proteinuria reduction and kidney function preservation. The trial consists of a 104-week double-blind treatment period, followed by a 52-week open-label extension and 26 weeks of follow-up.
